Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-01-01 @ 12:33 PM
Study NCT ID:
NCT06947057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-27
First Post:
2025-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Classifying Fully Guided Surgical Guides
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-20', 'studyFirstSubmitDate': '2025-04-20', 'studyFirstSubmitQcDate': '2025-04-20', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angular deviation', 'timeFrame': 'Immediately postoperative', 'description': 'The angle closed by the principal axis of the planned implant and the principal axis of the inserted implant in degrees'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Guided implant'], 'conditions': ['Dental Prostheses']}, 'descriptionModule': {'briefSummary': 'Surgical guides can be classified according to support into tooth-supported, mucosa-supported, bone-supported, or a combination of these. Tooth-supported templates are further divided into unilateral or bilateral tooth support. Bilateral tooth-supported guides refer to templates that are supported by templates on both sides while unilateral tooth support refers to templates that is supported by teeth on one side and mucosa or bone from the other side. Usually, mucosa-supported guides are utilized in full arch cases in which there is no need for bone reduction. Stackable guides are the best option when bone reduction is indicated because they allow for the planning of both implant osteotomies and bone sculpturing using a single template made up of different components. This study compare all static guided protocols( bilateral tooth supported, unilateral tooth supported, full arch mucosa supported, stackable bone supported ) with each other under homogenous conditions.', 'detailedDescription': 'Surgical guides can be classified according to support into tooth-supported, mucosa-supported, bone-supported, or a combination of these. Tooth-supported templates are further divided into unilateral or bilateral tooth support. Bilateral tooth-supported guides refer to templates that are supported by templates on both sides while unilateral tooth support refers to templates that is supported by teeth on one side and mucosa or bone from the other side. Usually, mucosa-supported guides are utilized in full arch cases in which there is no need for bone reduction. Stackable guides are the best option when bone reduction is indicated because they allow for the planning of both implant osteotomies and bone sculpturing using a single template made up of different components.\n\nTheoretically, bilateral tooth-supported guides offer the most accuracy since they offer the best retention and biomechanical stability with anchorage on hard tissues. According to a recent systematic review, unilateral tooth guides exhibited higher deviations except in global coronal deviation where unilateral tooth-supported guides exhibited slightly lower distribution than bilateral guides, and in in vivo global apical deviation where bilateral and unilateral tooth-supported guides showed a similar data range.\n\nDespite the increasing predictability of guided surgery, there will always be differences between the virtual plan and actual performance. The accuracy of static computer-aided implant operations was assessed in the 2018 International Team for Implantology consensus document. According to the study, the variations for the mean crestal point, apical point, angle, coronal depth, and apical depth were 1.2 mm, 1.4 mm, 3.5 o, 0.2 mm, and 0.5 mm, respectively. A safety margin of 2 mm ought to be taken into account at all times, based on the previously indicated precision.\n\nFor the purposes of this study, accuracy is defined as the closeness of spatial agreement between any given implant as planned (reference) and as inserted (measurement), expressed by four spatial deviation parameters'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Missing either only one tooth or partially or fully edentulous.\n* Good oral hygiene.\n* Systemic free.\n\nExclusion Criteria:\n\n* Conditions that might render intraoral manipulation impossible (limited mouth opening, excessive gag reflex).\n* Bisphosphonate treatment (either at the time of screening or in the history).\n* Radiotherapy, irradiation of the mandible or the maxilla (either at the time of screening or in the history).\n* Smokers.\n* Untreated periodontal disease.'}, 'identificationModule': {'nctId': 'NCT06947057', 'briefTitle': 'Classifying Fully Guided Surgical Guides', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Classifying Fully Guided Surgical Guides: A Comprehensive Analysis of Accuracy', 'orgStudyIdInfo': {'id': '111333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unilateral tooth supported', 'description': 'Unilateral guided implant placement', 'interventionNames': ['Procedure: Guided implant placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral tooth supported', 'description': 'Bilateral guided implant placement', 'interventionNames': ['Procedure: Guided implant placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Full arch mucosa supported', 'description': 'Full arch implant placement mucosa supported', 'interventionNames': ['Procedure: Guided implant placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stackable bone supported', 'description': 'Stackable guide, foundation guide and on top implant placement guide', 'interventionNames': ['Procedure: Guided implant placement']}], 'interventions': [{'name': 'Guided implant placement', 'type': 'PROCEDURE', 'description': 'The four types of fully guided surgical guides (bilateral tooth-supported guides, unilateral tooth-supported guides, mucosa-supported full arch guides and stackable guides)', 'armGroupLabels': ['Bilateral tooth supported', 'Full arch mucosa supported', 'Stackable bone supported', 'Unilateral tooth supported']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Doaa Adel Salah Khattab', 'investigatorAffiliation': 'Ain Shams University'}}}}